Locally ablatiVe therApy in oLigO-pRogressive sOlid tUmorS (VALOROUS)

This is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. Participants will receive ablative local therapy per standard practices in addition to their systemic therapy and will be followed for up to 5 years following ablative local therapy. Participants will be assigned stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy per the discretion of treating radiation oncologist and/or interventional radiologist.

Inclusion criteria

• Must have one of the following histologically and/or biochemically confirmed genitourinary malignancies:

• Cohort A: Breast Malignancy
• Cohort B: Gynecological Malignancy
• Cohort C: Head and Neck Malignancies
• Cohort D: Sarcomas
• Cohort E: Other solid malignancy specified in the protocol
• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Age ≥18 years at time of consent.
• Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.
• ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. [Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment]
• ≤ 5 progressing or new metastatic lesions.
• All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.

Exclusion criteria

• Medical comorbidities precluding locally ablative therapies.
• History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
• Progressing intracranial lesions.